What is Medical Device Sales License and How to Obtain it?

What is Medical Device Sales License and How to Obtain it?

If you are planning to sell medical devices in India, you are stepping into a regulated activity whether you realize it or not. There is no grey area left anymore. The moment you stock, distribute, exhibit, or sell a medical device, Indian law treats you as a regulated entity. This is not a future requirement or a proposed rule. It is already in force.

Many businesses still ask whether a “medical device sales license” exists as a single document. In practice, it doesn’t exist under that exact name. What exists instead is a mandatory licensing or registration framework under which sale and distribution of medical devices is permitted only after approval from the appropriate authority.

Why Selling Medical Devices Is No Longer a Simple Trade Activity

Until a few years ago, medical devices were regulated unevenly. Some were treated like drugs, some were ignored entirely. That situation ended when the Government of India notified the Medical Devices Rules 2017 under the Drugs and Cosmetics Act 1940

Since then, and especially after subsequent CDSCO notifications, all medical devices intended to be sold in India must be regulated. This applies regardless of risk class. Even low-risk devices cannot be freely sold anymore.

If you are selling without a license today, you are not operating in a loophole. You are operating illegally.

Read More Medical Device Manufacturing License Registration in India (2026 Update)

What the Law Actually Requires You to Hold

From a legal standpoint, you are required to hold a license or registration that authorizes sale, stocking, exhibition, or distribution of medical devices.

This requirement is enforced through:

• The Drugs and Cosmetics Act, 1940
• The Medical Devices Rules, 2017
• Notifications and circulars issued by CDSCO

Depending on your role, the permission may be issued by:

• The State Licensing Authority, or
• The Central Licensing Authority (CDSCO)

Device Classification Matters, Even for Sales

You cannot avoid classification. Every medical device sold in India falls into one of four classes:

• Class A (low risk)
• Class B (low-moderate risk)
• Class C (moderate-high risk)
• Class D (high risk)

The classification determines:

• Documentation depth,
• Inspection requirements,
• Compliance obligations.

What it does not change is the requirement to be licensed for sale. All classes require authorization.

The Forms Used for Medical Device Sale Licensing

If you are applying as a distributor or seller, your application is typically made in Form MD-41, and upon approval, the authority issues Form MD-42.

These forms are not optional paperwork. They are the legal instruments that allow you to operate.

Authorities will examine:

• Your premises,
• Your storage facilities,
• Your record-keeping systems,
• And the qualifications of personnel involved.

What You Must Put in Place Before You Apply

This is where many applicants fail often unknowingly

Before applying you should already have:

• A registered business entity,
• A physical premises suitable for medical device storage,
• Documented procedures for handling and distribution,
• Clarity on which devices you intend to sell.

Authorities are not there to help you design your business. They verify whether your business already meets regulatory expectations.

How the Application Process Actually Works?

Once you submit your application it does not simply sit in a queue. It is reviewed. Clarifications are raised. Sometimes inspections are scheduled.

During inspection, officers typically look at:

• Storage conditions (temperature, cleanliness, segregation),
• Availability of device records,
• Authorization letters from manufacturers or importers,
• And whether your declared activities match reality.

This step is often underestimated. It shouldn’t be.

After the License Is Issued, Compliance Continues

Receiving the license does not mean the end of regulatory oversight. You are expected to:

• Maintain updated records,
• Comply with distribution and traceability norms,
• Cooperate during audits or inspections,
• Ensure products sold are properly licensed themselves.

If a device you sell is unlicensed your own sales license does not protect you

Read More MD 15: CDSCO Medical Device Import License?

Common Errors That Cause Rejection or Delay

Based on regulatory practice these issues come up repeatedly:

• Applying without understanding device classification
• Submitting incomplete product lists
• Mismatch between declared and actual premises
• Assuming import approval equals sales permission
• Relying on foreign certificates as a substitute for Indian licensing.

None of these assumptions hold up during scrutiny.

Why Many Businesses Choose Professional Regulatory Support

On paper, the process looks manageable. In reality, it involves interpretation of rules, coordination with authorities, and compliance planning.

This is why many companies work with consultants who deal with medical device regulations daily.

Agile Regulatory assists businesses by:

• Identifying the exact license pathway,
• Preparing applications aligned with regulatory expectations,
• Coordinating with state and central authorities,
• Reducing the risk of objections and rejections.

That kind of support often saves months.

Final Thoughts

Selling medical devices in India is no longer a simple business. It is a business that is controlled by the law. You need to have the right license from the Medical Devices Rules 2017 if you want to sell, stock, or distribute medical devices.

Be clear, ready, and respectful of what the rules say when you go through the process. If you want help from someone who knows what they're doing, an plan Agile Regulatory can help you follow the rules and feel good about the process